Company ยท US
Skytron, Div. The KMW Group, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2007. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTD | Lamp, Surgical | 11 |
| FQO | Table, Operating-Room, Ac-Powered | 8 |
| FSY | Light, Surgical, Ceiling Mounted | 6 |
| GDC | Table, Operating-Room, Electrical | 5 |
| LMD | System, Digital Image Communications, Radiological | 2 |
| FLE | Sterilizer, Steam | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 |
| FWW | Table, Operating-Room, Pneumatic | 1 |
| FWY | Table, Operating-Room, Non-Electrical | 1 |
| GBC | Lamp, Surgical, Incandescent | 1 |
| HBN | Chair, Neurosurgical | 1 |
| INX | Bed, Air Fluidized | 1 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2007 | K071698 | AURORA LED SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc. | FSY |
| Nov 13, 2002 | K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES Skytron, Div. the Kmw Group, Inc. | FSY |
| Nov 8, 2000 | K002463 | STELLAR Skytron, Div. the Kmw Group, Inc. | FSY |
| Sep 8, 1999 | K992090 | MILLENNIUM GOLD Skytron, Div. the Kmw Group, Inc. | FSY |
| Apr 3, 1995 | K950192 | SKYTRON SKYBOOM SERIES Skytron, Div. the Kmw Group, Inc. | FQO |
| Jun 13, 1994 | K940616 | SKYTRON ELITE 3500 TABLE Skytron, Div. the Kmw Group, Inc. | GDC |
| Feb 10, 1994 | K933564 | SKYTRON EXAM LIGHT Skytron, Div. the Kmw Group, Inc. | KZF |
| Jul 27, 1993 | K926045 | SKYTRON LIFE ISLAND 21 Skytron, Div. the Kmw Group, Inc. | FNM |
| Feb 20, 1992 | K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc. | FSY |
| Sep 4, 1990 | K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI Skytron, Div. the Kmw Group, Inc. | HBN |
| Mar 19, 1990 | K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc. | FSY |
| Feb 20, 1990 | K900290 | SKYTRON MODEL 1100 AND MODEL 142 Skytron, Div. the Kmw Group, Inc. | JEA |
| Sep 24, 1987 | K873478 | SKYTRON MODEL 130 SURGICAL TABLE Skytron, Div. the Kmw Group, Inc. | FWY |
| Feb 4, 1987 | K870045 | SKYTRON MODEL 610-2 Skytron, Div. the Kmw Group, Inc. | INX |
| Sep 12, 1985 | K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES Skytron, Div. the Kmw Group, Inc. | GDC |
| Sep 5, 1985 | K853479 | SKYTRON ELITE 300 SURGERY TABLE Skytron, Div. the Kmw Group, Inc. | FWW |
| May 17, 1985 | K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE Skytron, Div. the Kmw Group, Inc. | GDC |
| May 17, 1985 | K851829 | SKYTRON ELITE 3100 SURGICAL TABLE Skytron, Div. the Kmw Group, Inc. | GDC |
| Jun 2, 1981 | K811311 | SKYTRON ELITE SURGICAL TABLES Skytron, Div. the Kmw Group, Inc. | GBC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2022 | Skytron, Div. The KMW Group, Inc Product Name: GCX Channel Mounting Accessory
Model/Catalog Number: H8-300-40-A Open, Classified |
FQO | None listed |
| Jun 15, 2021 | Skytron, Div. The KMW Group, Inc Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor.
Model: FS32 Open, Classified |
FQO | None listed |
| Sep 11, 2020 | Skytron, Div. The KMW Group, Inc VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System
Model: VGDF-SKY (version 2). For communication and visual image m Terminated |
LMD | None listed |
| Mar 10, 2020 | Skytron, Div. The KMW Group, Inc SkyVision SDS System - Video Integration
Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room. Terminated |
LMD | None listed |
| Mar 5, 2020 | Skytron, Div. The KMW Group, Inc Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size
Part number 3FCM1 Open, Classified |
FQO | K950192 |
| Apr 18, 2019 | Skytron, Div. The KMW Group, Inc Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam
Product Usage:
The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorpor Terminated |
FLE | K132439 |
| May 31, 2016 | Skytron, Div. The KMW Group, Inc EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide
General Purpose Surgical Table
Skytron EZ Slide Operating Table
General Purpose Surgical Table Terminated |
GDC | None listed |
| May 31, 2016 | Skytron, Div. The KMW Group, Inc Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size Terminated |
FQO | K950192 |
| Jan 14, 2016 | Skytron, Div. The KMW Group, Inc Ergon 2 Articulating Equipment Boom Monitor Brackets
mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on t Terminated |
FQO | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL a Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3 Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/ Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, I Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL. Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S. Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S. Terminated |
FTD | K915285 |
| Sep 13, 2006 | Skytron, Div. The KMW Group, Inc Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Grand Rapids, MI. Terminated |
FQO | K950192 |
| Sep 13, 2006 | Skytron, Div. The KMW Group, Inc Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI. Terminated |
FQO | K950192 |